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Alkermes

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https://www.readbyqxmd.com/read/29150198/comparative-effectiveness-of-extended-release-naltrexone-versus-buprenorphine-naloxone-for-opioid-relapse-prevention-x-bot-a-multicentre-open-label-randomised-controlled-trial
#1
Joshua D Lee, Edward V Nunes, Patricia Novo, Ken Bachrach, Genie L Bailey, Snehal Bhatt, Sarah Farkas, Marc Fishman, Phoebe Gauthier, Candace C Hodgkins, Jacquie King, Robert Lindblad, David Liu, Abigail G Matthews, Jeanine May, K Michelle Peavy, Stephen Ross, Dagmar Salazar, Paul Schkolnik, Dikla Shmueli-Blumberg, Don Stablein, Geetha Subramaniam, John Rotrosen
BACKGROUND: Extended-release naltrexone (XR-NTX), an opioid antagonist, and sublingual buprenorphine-naloxone (BUP-NX), a partial opioid agonist, are pharmacologically and conceptually distinct interventions to prevent opioid relapse. We aimed to estimate the difference in opioid relapse-free survival between XR-NTX and BUP-NX. METHODS: We initiated this 24 week, open-label, randomised controlled, comparative effectiveness trial at eight US community-based inpatient services and followed up participants as outpatients...
November 14, 2017: Lancet
https://www.readbyqxmd.com/read/28839338/metabolic-and-endocrine-profiles-during-1-year-treatment-of-outpatients-with-schizophrenia-with-aripiprazole-lauroxil
#2
Henry A Nasrallah, Ralph Aquila, Arielle D Stanford, Hasan H Jamal, Peter J Weiden, Robert Risinger
BACKGROUND: We assessed long-term metabolic and endocrine profiles of outpatients with schizophrenia participating in a one-year open-label extension study of monthly aripiprazole lauroxil (AL), a long-acting injectable antipsychotic. METHODS: Patients (N = 478) were enrolled in a 52-week, open-label extension study of AL monotherapy administered by intramuscular injection every 4 weeks. Of these, most (368) received AL 882 mg and the remainder AL 441 mg as their fixed-dose regimen...
August 1, 2017: Psychopharmacology Bulletin
https://www.readbyqxmd.com/read/28636480/the-emerging-role-of-pimavanserin-in-the-management-of-parkinson-s-disease-psychosis
#3
Neal Hermanowicz, Gustavo Alva, Fernando Pagan, Alberto J Espay, Amita Patel, Katya Cruz Madrid, Daniel Kremens, Jim Kenney, Sheila Arquette, Gary Tereso, Maria Lopes, Carolyn Farnum
A panel of experts drawn from neurology, psychiatry, geropsychiatry, geriatrics, and pharmacy representatives of 3 health plans convened in New York City on July 30, 2016, with the objective of sharing opinions, ideas, and information regarding the optimal management of Parkinson's disease psychosis (PDP). Three key points emerged from the discussion: (1) Because of the nature of Parkinson's disease and PDP, finding appropriate treatment can prove challenging; (2) emerging therapies may present an opportunity for effective disease management; and (3) moving forward, provider and patient education regarding PDP and available treatment options is essential for well-managed symptoms and better quality of life...
June 2017: Journal of Managed Care & Specialty Pharmacy
https://www.readbyqxmd.com/read/28603465/spinal-cord-as-an-adjunct-to-brain-magnetic-resonance-imaging-in-defining-no-evidence-of-disease-activity-in-multiple-sclerosis
#4
Subhash Tummala, Tarun Singhal, Vinit V Oommen, Gloria Kim, Fariha Khalid, Brian C Healy, Rohit Bakshi
Background: Monitoring patients with multiple sclerosis (MS) for “no evidence of disease activity” (NEDA) may help guide disease-modifying therapy (DMT) management decisions. Whereas surveillance brain magnetic resonance imaging (MRI) is common, the role of spinal cord monitoring for NEDA is unknown. Objective: To evaluate the role of brain and spinal cord 3T MRI in the 1-year evaluation of NEDA. Methods: Of 61 study patients (3 clinically isolated syndrome, 56 relapsing-remitting, 2 secondary progressive), 56 (91...
May 2017: International Journal of MS Care
https://www.readbyqxmd.com/read/27707530/effect-of-patient-age-on-treatment-response-in-a-study-of-the-acute-exacerbation-of-psychosis-in-schizophrenia
#5
Steven D Targum, Robert Risinger, Yangchun Du, J Cara Pendergrass, Hassan H Jamal, Bernard L Silverman
Younger patients with schizophrenia have most likely experienced fewer adverse consequences of the illness than older patients who may have experienced a lifetime of treatment as well as socio-economic problems as a consequence of the illness. There is limited information regarding differential efficacy of long-acting injectable (LAI) antipsychotic medications across the age span in patients with schizophrenia. We conducted a post hoc age and gender analysis of treatment response to aripiprazole lauroxil (AL; ARISTADA®; Alkermes, Inc...
January 2017: Schizophrenia Research
https://www.readbyqxmd.com/read/27703782/ketamine-stimulating-antidepressant-treatment
#6
EDITORIAL
Gin S Malhi, Yulisha Byrow, Frederick Cassidy, Andrea Cipriani, Koen Demyttenaere, Mark A Frye, Michael Gitlin, Sidney H Kennedy, Terence A Ketter, Raymond W Lam, Rupert McShane, Alex J Mitchell, Michael J Ostacher, Sakina J Rizvi, Michael E Thase, Mauricio Tohen
SUMMARY: The appeal of ketamine - in promptly ameliorating depressive symptoms even in those with non-response - has led to a dramatic increase in its off-label use. Initial promising results await robust corroboration and key questions remain, particularly concerning its long-term administration. It is, therefore, timely to review the opinions of mood disorder experts worldwide pertaining to ketamine's potential as an option for treating depression and provide a synthesis of perspectives - derived from evidence and clinical experience - and to consider strategies for future investigations...
May 2016: BJPsych Open
https://www.readbyqxmd.com/read/27282118/injectable-pharmacotherapy-for-opioid-use-disorders-ipod
#7
David Farabee, Maureen Hillhouse, Timothy Condon, Barbara McCrady, Kathryn McCollister, Walter Ling
BACKGROUND: Despite the growing prevalence of opioid use among offenders, pharmacotherapy remains an underused treatment approach in correctional settings. The aim of this 4-year trial is to assess the clinical utility, effectiveness, and cost implications of extended-release naltrexone (XR-NTX, Vivitrol®; Alkermes Inc.) alone and in conjunction with patient navigation for jail inmates with opioid use disorder (OUD). METHODS: Opioid-dependent inmates will be randomly assigned to one of three treatment conditions before being released to the community to include: 1) XR-NTX only; 2) XR-NTX plus patient navigation (PN), and 3) enhanced treatment-as-usual (ETAU) with drug education and a community treatment referral...
July 2016: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/25703440/opioid-treatment-at-release-from-jail-using-extended-release-naltrexone-a-pilot-proof-of-concept-randomized-effectiveness-trial
#8
RANDOMIZED CONTROLLED TRIAL
Joshua D Lee, Ryan McDonald, Ellie Grossman, Jennifer McNeely, Eugene Laska, John Rotrosen, Marc N Gourevitch
BACKGROUND AND AIMS: Relapse to addiction following incarceration is common. We estimated the feasibility and effectiveness of extended-release naltrexone (XR-NTX) as relapse prevention among opioid-dependent male adults leaving a large urban jail. DESIGN: Eight-week, proof-of-concept, open-label, non-blinded randomized effectiveness trial. SETTING: New York City jails and Bellevue Hospital Center Adult Primary Care clinics, USA. PARTICIPANTS: From January 2010 to July 2013, 34 opioid-dependent adult males with no stated interest in agonist treatments (methadone, buprenorphine) received a counseling and referral intervention and were randomized to XR-NTX (n = 17) versus no medication (n = 17) within one week prior to jail release...
June 2015: Addiction
https://www.readbyqxmd.com/read/25602580/extended-release-naltrexone-to-prevent-relapse-among-opioid-dependent-criminal-justice-system-involved-adults-rationale-and-design-of-a-randomized-controlled-effectiveness-trial
#9
RANDOMIZED CONTROLLED TRIAL
Joshua D Lee, Peter D Friedmann, Tamara Y Boney, Randall A Hoskinson, Ryan McDonald, Michael Gordon, Marc Fishman, Donna T Chen, Richard J Bonnie, Timothy W Kinlock, Edward V Nunes, James W Cornish, Charles P O'Brien
BACKGROUND: Extended-release naltrexone (XR-NTX, Vivitrol; Alkermes Inc.) is an injectable monthly sustained-release mu opioid receptor antagonist. XR-NTX is a potentially effective intervention for opioid use disorders and as relapse prevention among criminal justice system (CJS) populations. METHODS: This 5-site open-label randomized controlled effectiveness trial examines whether XR-NTX reduces opioid relapse compared with treatment as usual (TAU) among community dwelling, non-incarcerated volunteers with current or recent CJS involvement...
March 2015: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/21529928/injectable-extended-release-naltrexone-for-opioid-dependence-a-double-blind-placebo-controlled-multicentre-randomised-trial
#10
RANDOMIZED CONTROLLED TRIAL
Evgeny Krupitsky, Edward V Nunes, Walter Ling, Ari Illeperuma, David R Gastfriend, Bernard L Silverman
BACKGROUND: Opioid dependence is associated with low rates of treatment-seeking, poor adherence to treatment, frequent relapse, and major societal consequences. We aimed to assess the efficacy, safety, and patient-reported outcomes of an injectable, once monthly extended-release formulation of the opioid antagonist naltrexone (XR-NTX) for treatment of patients with opioid dependence after detoxification. METHODS: We did a double-blind, placebo-controlled, randomised, 24-week trial of patients with opioid dependence disorder...
April 30, 2011: Lancet
https://www.readbyqxmd.com/read/20878582/american-chemical-society-240th-national-meeting-chemistry-for-preventing-and-combating-disease-part-1
#11
Jessica Burt
The 240th National Meeting of the American Chemical Society, held in Boston, included topics covering new therapeutic research. This conference report highlights selected presentations on negative allosteric modulators of metabotropic glutamate receptor 5 (mGluR5) for the treatment of Parkinson's disease, BACE1 inhibitors and γ-secretase inhibitors for the prevention or treatment of Alzheimer's disease, opioid modulators for the treatment of reward disorders, SGLT2 inhibitors for the treatment of diabetes, backup compounds to the DPP-4 inhibitor sitagliptin (Januvia) for type 2 diabetes, and MCH R1 inhibitors for the treatment of obesity...
October 2010: IDrugs: the Investigational Drugs Journal
https://www.readbyqxmd.com/read/19943210/society-for-neuroscience-39th-annual-meeting-part-1-novel-therapies-for-the-treatment-of-cns-disorders-and-pain
#12
Asma Al-Shamahi, Konrad Kirkham, Livia Hookes
The 39th Annual Meeting of the Society for Neuroscience (SFN), held in Chicago, included topics covering new therapeutic developments in the field of neuroscience. This conference report highlights selected presentations on nicotinic ACh receptor alpha7 agonists, cannabinoid CB2 receptor agonists, transient receptor potential channel antagonists, spinal mechanotransmission modulation, a COX-1 inhibitor, a NaV/CaV blocker, an opioid modulator and a novel triple reuptake inhibitor with potential antidepressant, anxiolytic and analgesic activity...
December 2009: IDrugs: the Investigational Drugs Journal
https://www.readbyqxmd.com/read/19772452/air-insulin-capsules-of-different-dose-strengths-may-be-combined-to-yield-equivalent-pharmacokinetics-and-glucodynamics
#13
RANDOMIZED CONTROLLED TRIAL
Amparo de la Peña, Mary Seger, Klaus Rave, Lutz Heinemann, Bernard Silverman, Douglas B Muchmore
BACKGROUND: In order to assess pharmacokinetic (PK) and glucodynamic (GD) attributes relevant to the end user of an inhaled insulin, this study examined the exposure and GD effect of doses of AIR inhaled insulin (Eli Lilly and Co., Indianapolis, IN) (AIR is a registered trademark of Alkermes, Inc., Cambridge, MA) by combining capsules of different strengths in healthy subjects. METHODS: Fifty-nine healthy, nonsmoking, male or female subjects with normal pulmonary function were enrolled in an open-label, randomized, crossover study...
September 2009: Diabetes Technology & Therapeutics
https://www.readbyqxmd.com/read/19772451/comparison-of-prandial-air-inhaled-insulin-alone-to-intensified-insulin-glargine-alone-and-to-air-insulin-plus-intensified-insulin-glargine-in-patients-with-type-2-diabetes-previously-treated-with-once-daily-insulin-glargine
#14
RANDOMIZED CONTROLLED TRIAL
Julio Rosenstock, Freddy G Eliaschewitz, Cory R Heilmann, Douglas B Muchmore, Risa P Hayes, Ruth M Belin
BACKGROUND: Patients with type 2 diabetes often initiate insulin with once-daily basal insulin. Over time, many patients intensify their insulin regimens in an attempt to attain and sustain glycemic targets. This study compares three intensification approaches: changing insulin glargine to preprandial AIR inhaled insulin (developed by Alkermes, Inc. [Cambridge, MA] and Eli Lilly and Company [Indianapolis, IN]; AIR is a registered trademark of Alkermes, Inc.), intensifying glargine via validated titration algorithms (IG), or adding AIR insulin while intensifying glargine (AIR + IG)...
September 2009: Diabetes Technology & Therapeutics
https://www.readbyqxmd.com/read/19772450/a-comparison-between-simplified-and-intensive-dose-titration-algorithms-using-air-inhaled-insulin-for-insulin-naive-patients-with-type-2-diabetes-in-a-randomized-noninferiority-trial
#15
RANDOMIZED CONTROLLED TRIAL
C Mathieu, R Cuddihy, R F Arakaki, R M Belin, J-M Planquois, J N Lyons, C R Heilmann
BACKGROUND: Insulin initiation and optimization is a challenge for patients with type 2 diabetes. Our objective was to determine whether safety and efficacy of AIR inhaled insulin (Eli Lilly and Co., Indianapolis, IN) (AIR is a registered trademark of Alkermes, Inc., Cambridge, MA) using a simplified regimen was noninferior to an intensive regimen. METHODS: This was an open-label, randomized study in insulin-naive adults not optimally controlled by oral antihyperglycemic medications...
September 2009: Diabetes Technology & Therapeutics
https://www.readbyqxmd.com/read/19772449/two-year-efficacy-and-safety-of-air-inhaled-insulin-in-patients-with-type-1-diabetes-an-open-label-randomized-controlled-trial
#16
RANDOMIZED CONTROLLED TRIAL
Satish K Garg, Chantal Mathieu, Nadeem Rais, Haitao Gao, Janet A Tobian, Jeffrey R Gates, Jeffrey A Ferguson, David M Webb, Pierre-Yves Berclaz
BACKGROUND: Patients with type 1 diabetes require intensive insulin therapy for optimal glycemic control. AIR((R)) inhaled insulin (system from Eli Lilly and Company, Indianapolis, IN) (AIR is a registered trademark of Alkermes, Inc., Cambridge, MA) may be an efficacious and safe alternative to subcutaneously injected (SC) mealtime insulin. METHODS: This was a Phase 3, 2-year, randomized, open-label, active-comparator, parallel-group study in 385 patients with type 1 diabetes who were randomly assigned to receive AIR insulin or SC insulin (regular human insulin or insulin lispro) at mealtimes...
September 2009: Diabetes Technology & Therapeutics
https://www.readbyqxmd.com/read/19772448/does-availability-of-air-insulin-increase-insulin-use-and-improve-glycemic-control-in-patients-with-type-2-diabetes
#17
RANDOMIZED CONTROLLED TRIAL
Richard M Bergenstal, Nick Freemantle, Malgorzata Leyk, Gordon B Cutler, Risa P Hayes, Douglas B Muchmore
BACKGROUND: In the concordance model, physician and patient discuss treatment options, explore the impact of treatment decisions from the patient's perspective, and make treatment choices together. We tested, in a concordance setting, whether the availability of AIR inhaled insulin (developed by Alkermes, Inc. [Cambridge, MA] and Eli Lilly and Company [Indianapolis, IN]; AIR is a registered trademark of Alkermes, Inc.), as compared with existing treatment options alone, leads to greater initiation and maintenance of insulin therapy and improves glycemic control in patients with type 2 diabetes...
September 2009: Diabetes Technology & Therapeutics
https://www.readbyqxmd.com/read/19772447/safety-and-efficacy-of-air-inhaled-insulin-compared-with-subcutaneous-insulin-in-patients-having-diabetes-and-asthma-a-12-month-randomized-noninferiority-trial
#18
RANDOMIZED CONTROLLED TRIAL
Ernesto Ang, Mary K Lawrence, Cory R Heilmann, Jeffrey A Ferguson, Janet A Tobian, David M Webb, Pierre-Yves Berclaz
BACKGROUND: Long-term safety and efficacy of AIR((R)) inhaled insulin (Eli Lilly and Co., Indianapolis, IN) (AIR is a registered trademark of Alkermes, Inc., Cambridge, MA) in patients with diabetes and concomitant lung disease remain to be established. METHODS: This 1-year, randomized, open-label, active comparator, two-arm, parallel study compared the safety and efficacy of AIR insulin to subcutaneous (SC) insulin in patients having type 1 or type 2 diabetes and asthma...
September 2009: Diabetes Technology & Therapeutics
https://www.readbyqxmd.com/read/19772446/initiation-of-prandial-insulin-therapy-with-air-inhaled-insulin-or-insulin-lispro-in-patients-with-type-2-diabetes-a-randomized-noninferiority-trial
#19
RANDOMIZED CONTROLLED TRIAL
Jorge L Gross, Masako Nakano, Gildred Colon-Vega, Ramon Ortiz-Carasquillo, Jeffrey A Ferguson, Sandra Althouse, Janet A Tobian, Pierre-Yves Berclaz, Zvonko Milicevic
BACKGROUND: Insulin initiation in patients with type 2 diabetes is often delayed because of concerns about injections. Our objective was to compare the effects of AIR inhaled insulin (Eli Lilly and Co., Indianapolis, IN) (AIR is a registered trademark of Alkermes, Inc., Cambridge, MA) with those of injectable insulin on glycemic control and safety. METHODS: This was planned as a 24-month, open-label, randomized study in adults with diabetes inadequately controlled by one or more oral antihyperglycemic medications (OAMs)...
September 2009: Diabetes Technology & Therapeutics
https://www.readbyqxmd.com/read/19772445/efficacy-and-safety-of-air-inhaled-insulin-compared-to-insulin-lispro-in-patients-with-type-1-diabetes-mellitus-in-a-6-month-randomized-noninferiority-trial
#20
RANDOMIZED CONTROLLED TRIAL
Angel L Comulada, Eric Renard, Masako Nakano, Nadeem Rais, Xuejing Mao, David M Webb, Zvonko Milicevic
BACKGROUND: Patients with type 1 diabetes may prefer features of AIR inhaled insulin (developed by Alkermes, Inc. [Cambridge, MA] and Eli Lilly and Company [Indianapolis, IN]; AIR is a registered trademark of Alkermes, Inc.) over insulin injection, but the two methods need to be compared for efficacy and safety. METHODS: This multicenter, 6-month, parallel-group, noninferiority trial had 500 patients with type 1 diabetes randomized to morning doses of basal insulin glargine plus either preprandial injectable insulin lispro or preprandial AIR insulin...
September 2009: Diabetes Technology & Therapeutics
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